Sanofi Pasteur expands C.difficile clinical trial into US
Sanofi Pasteur, the vaccines division of the Sanofi-aventis Group, is expanding its phase II clinical study of a vaccine against Clostridium difficile infection (CDI) into the US. The trial started in the UK earlier this year.
Sanofi Pasteur, the vaccines division of the Sanofi-aventis Group, is expanding its phase II clinical study of a vaccine against Clostridium difficile infection (CDI) into the US. The trial started in the UK earlier this year.
The incidence of CDI has increased significantly in recent years in both North America and Europe. CDI-related treatments in these two regions are estimated to be costing more than US$7bn a year.
"While the target indication for the vaccine is prevention, this trial - in recently infected patients - aims to provide early proof-of-concept of a vaccine approach to preventing recurring infection," said Michel DeWilde, senior vice president of r&d at Sanofi Pasteur.
"Recurring infection occurs in at least 20% of patients experiencing a first CDI episode and even higher frequency in those who have had multiple episodes," he said.
Current treatment of C.difficile infection involves the use of one of two antibiotics. The US trial will investigate the safety and efficacy of Sanofi Pasteur's CDI candidate vaccine.
"Non-antibiotic approaches for managing CDI are badly needed since antibiotics alter the gut microflora and permit the infection in the first place," added DeWilde. "There is also considerable concern about the emergence of antibiotic-resistance in various bacterial species, including C.difficile.
"Vaccination has the potential to be a very effective strategy to combat the gastrointestinal symptoms caused by C.difficile in conjunction with better antibiotic stewardship and infection control practices."
Sanofi Pasteur's candidate vaccine uses a toxoid-based approach, which has been used extensively in licensed vaccines against tetanus, diphtheria and whooping cough. It has successfully completed phase I clinical trials in more than 200 participants.
The phase IIb trial hopes to recruit approximately 600 participants with acute CDI across the UK and US. Participants will be randomised to four study groups, where three groups will receive the vaccine and the fourth group a placebo.